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A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

Trial Profile

A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Dec 2023

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At a glance

  • Drugs Trastuzumab-duocarmazine (Primary) ; Capecitabine; Eribulin; Lapatinib; Trastuzumab; Trastuzumab; Vinorelbine
  • Indications Advanced breast cancer; HER2 positive breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TULIP
  • Sponsors Byondis; Synthon Pharmaceuticals

Most Recent Events

  • 24 Oct 2023 Final Results presented at the 48th European Society for Medical Oncology Congress.
  • 22 May 2023 Status changed from active, no longer recruiting to completed.
  • 15 May 2023 According to a Byondis media release, the FDA suspends the decision on the product's approvability. The agency requested additional information that requires time and resources that extend beyond the current evaluation period.

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